Novavax NVX-CoV2373

NVX-CoV2373 is a protein subunit vaccine for Covid-19 from Novavax. It was the first protein sub-unit vaccine to be approved in Europe or the USA.

NVX-CoV2373 is engineered from the genetic sequence of the first strain of SARS-CoV-2. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate.

Novavax' COVID-19 vaccine is packaged as a liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius.

Marketing Name: Nuvaxovid, CovoVax (in India, Indonesia)

Funded, in part, by Operation Warp Speed (OWS).

Patent: US20210228709A1

2020-01-27 Priority to US202062966271P

2021-03-18 Application filed by Novavax Inc

2021-07-29 Publication of US20210228709A1

2022-02-22 Application granted

2022-02-22 Publication of US11253586B2

Status Active 2040-08-19

Anticipated expiration

SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 immunogenicity in baboons and protection in mice¹⁾

Clinical Trial Phase I/II:

• Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine²⁾
• Immunogenicity and Safety Following a Homologous Booster Dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): A Phase 2 Randomized Placebo-Controlled Trial³⁾

Clinical Trial Phase III:

• PREVENT-19: Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine (North and South America)in NEJM⁴⁾ and factsheet⁵⁾
  
• Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine (UK) ⁶⁾

• Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.1.7 Variant⁷⁾

November 1, 2021: Indonesia⁸⁾
November 17, 2021: Philippines⁹⁾
December 17, 2021: World Health Organization (WHO) granted Emergency Use Listing for Covovax.¹⁰⁾
December 20, 2021: EMA granted conditional marketing authorization.¹¹⁾
December 28, 2021: The Drugs Controller General of India (DCGI) has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.¹²⁾
February 3, 2022: England, Scotland and Wales granted EUA.¹³⁾